Document Detail

Phase I study of concurrent weekly docetaxel, high-dose intensity-modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) for high-risk prostate cancer.
MedLine Citation:
PMID:  23016517     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: •  To evaluate in a phase I trial, the feasibility of adding concurrent weekly docetaxel chemotherapy to high-dose intensity modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) for treatment of high-risk prostate cancer.
PATIENTS AND METHODS: •  Patients with high-risk prostate cancer were treated with a luteinising hormone-releasing hormone agonist (starting 2-3 months before IMRT and lasting 2 years), IMRT of 78 Gy to the prostate and seminal vesicles, and weekly docetaxel during RT. •  All patients had computed tomography and bone scans to exclude metastatic disease. •  A standard 3 + 3 design was used for docetaxel dose escalation. Successive patients were treated on dose levels of 10, 15, and 20 mg/m(2) of weekly docetaxel.
RESULTS: •  In all, 18 patients participated in the study: 15 (83%) had Gleason 8-10 disease; the other three had either clinical T3 disease and/or a prostate-specific antigen (PSA) level of >20 ng/mL. •  Grade 3 diarrhoea (a defined dose-limiting toxicity, DLT) occurred in one patient in each of the first two dose levels. However, when the cohorts were expanded, no further DLT was seen. •  Weekly docetaxel at 20 mg/m(2) (dose level 3) was successfully given without DLT. •  No patient had grade 4 or 5 toxicity. •  At a median follow-up of 2.2 years, all patients achieved a PSA nadir of <1 ng/mL, including 13 patients who had an undetectable PSA level. The 2-year biochemical progression-free survival was 94%.
CONCLUSION: •  A dose of 20 mg/m(2) of weekly docetaxel given concurrently with high-dose IMRT and ADT appears safe for further study in patients with high-risk prostate cancer.
Ronald C Chen; Julian G Rosenman; Leroy G Hoffman; Wing-Keung Chiu; Andrew Z Wang; Raj S Pruthi; Eric M Wallen; Jeffrey M Crane; William Y Kim; W Kimryn Rathmell; Paul A Godley; Young E Whang
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Publication Detail:
Type:  Clinical Trial, Phase I; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-09-27
Journal Detail:
Title:  BJU international     Volume:  110     ISSN:  1464-410X     ISO Abbreviation:  BJU Int.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2013-03-07     Completed Date:  2013-04-23     Revised Date:  2013-05-28    
Medline Journal Info:
Nlm Unique ID:  100886721     Medline TA:  BJU Int     Country:  England    
Other Details:
Languages:  eng     Pagination:  E721-6     Citation Subset:  IM    
Copyright Information:
Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7295, USA.
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MeSH Terms
Androgen Antagonists / administration & dosage*
Antineoplastic Agents / administration & dosage
Disease-Free Survival
Dose-Response Relationship, Drug
Follow-Up Studies
Gonadotropin-Releasing Hormone / antagonists & inhibitors
Middle Aged
Neoplasm Staging
Prospective Studies
Prostate-Specific Antigen / blood
Prostatic Neoplasms / drug therapy*,  pathology,  radiotherapy
Radiation-Sensitizing Agents
Radiotherapy Dosage
Radiotherapy, Intensity-Modulated / methods*
Taxoids / administration & dosage*
Treatment Outcome
Reg. No./Substance:
0/Androgen Antagonists; 0/Antineoplastic Agents; 0/Radiation-Sensitizing Agents; 0/Taxoids; 15H5577CQD/docetaxel; 33515-09-2/Gonadotropin-Releasing Hormone; EC Antigen

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